FDASeptember 26, 2025device
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
What to do
FDA enforcement status: Ongoing
Brands named
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UPCs
10886982301413
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCResistance Bands Recalled Due to Serious Injury from Impact Hazard; Imported by HomeProGym2026-05-21
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- FDADairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box2026-05-18
- FDALegacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags2026-05-18
- FDADairy House Ingredient Systems Strawberry Dairy Powder 05#5072-50, 50 lb bags2026-05-18
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